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Last Updated: December 7, 2022

Zolpidem tartrate - Generic Drug Details


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What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Aytu, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Breckenridge, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys, Mylan, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty-one NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has one hundred and forty-five patent family members in twenty-three countries.

There are thirty-two drug master file entries for zolpidem tartrate. Forty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for zolpidem tartrate

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Drug Sales Revenue Trends for zolpidem tartrate

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Recent Clinical Trials for zolpidem tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 4
National Institute on Aging (NIA)Phase 4
University of PennsylvaniaPhase 4

See all zolpidem tartrate clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for zolpidem tartrate
Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INTERMEZZO Sublingual Tablets zolpidem tartrate 1.75 mg and 3.5 mg 022328 1 2012-04-10
EDLUAR Sublingual Tablets zolpidem tartrate 5 mg and 10 mg 021997 1 2010-04-29
AMBIEN CR Extended-release Tablets zolpidem tartrate 6.25 mg 021774 1 2006-02-24
AMBIEN CR Extended-release Tablets zolpidem tartrate 12.5 mg 021774 1 2006-01-19

US Patents and Regulatory Information for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055-001 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055-002 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077359-002 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Industries ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077288-001 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Pharms Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078016-002 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Synthon Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077540-002 Apr 23, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for zolpidem tartrate

International Patents for zolpidem tartrate

Country Patent Number Title Estimated Expiration
Slovenia 1807156 See Plans and Pricing
European Patent Office 1549290 CAPSULE OU VAPORISATEUR BUCCAL, POLAIRE ET NON POLAIRE, CONTENANT DES MEDICAMENTS POUR LE TRAITEMENT DE TROUBLES METABOLIQUES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING METABOLIC DISORDERS) See Plans and Pricing
Canada 2582008 SPRAY NON POLAIRE, POLAIRE ET BUCCAL CONTENANT DU SUMATRIPTAN (BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING SUMATRIPTAN) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004019911 See Plans and Pricing
New Zealand 563979 Solid compositions and methods for treating middle-of-the night insomnia See Plans and Pricing
Japan 2006505611 See Plans and Pricing
Australia 2003270014 BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING CARDIOVASCULAR OR RENAL DRUGS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for zolpidem tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 C300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 92636 Luxembourg See Plans and Pricing PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 CA 2015 00004 Denmark See Plans and Pricing PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132 122015000006 Germany See Plans and Pricing PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Merck

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